Quality Assurance Manager for Regulatory Compliance
hace 2 meses
Nextern is seeking an experienced Senior Quality Engineer to join our team. As a Senior Quality Engineer, you will be responsible for ensuring quality requirements are met between Nextern and customers.
About the Role
This role involves managing quality expectations and daily requirements in engineering, production, and supply chain. You will lead complaint and CAPA investigations, perform internal audits, and lead changes to QMS documents. Additionally, this role will have supervisory responsibilities and involve defining strategies and providing mentorship on technical issues.
Key Responsibilities
- Lead complaint and CAPA investigations to ensure timely resolution and corrective actions.
- Communicate directly with clients to understand their needs and expectations.
- Perform internal audits to identify areas for improvement and maintain compliance with regulatory requirements.
- Lead changes to QMS documents to reflect updates and improvements.
- Lead multidisciplinary groups for high complexity projects, ensuring effective collaboration and coordination.
- Validate processes and systems to ensure they meet regulatory requirements.
- Execute IIR and FAIR reports to provide insight into quality performance.
- Support engineering activities to ensure quality standards are met.
- Lead quality activities for product development and transfer, ensuring seamless execution.
- Mentor junior colleagues in Investigations and Root Cause Analysis tools.
- Provide support to other engineering areas as needed.
- Participate in development projects and perform NPI activities, driving innovation and growth.
Requirements
- Bachelor's degree in engineering or a life sciences-related major.
- 6-8 years of experience in engineering/quality in a highly regulated manufacturing/industry environment.
- High English proficiency level.
Estimated Salary: $120,000 - $150,000 per year, depending on location and experience.
About Nextern
Nextern is a leading company in the industry, committed to delivering high-quality products and services. We offer a competitive compensation package and optimal working environment.
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